Manufacturing Technician II
Resilience is a technology-focused biomanufacturing company changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
About the role
This position will require working in various Controlled/Non-Classified areas. The Packaging Technician performs a variety of manufacturing tasks (operates equipment, performs in-process monitoring, line clearances, cosmetic inspection, cleaning, and completes batch record entries) and supports improvement activities (5S, participates in problem-solving and Kaizen events, manual data collection) to achieve a prescribed level of purity, quality, and consistency in product and work output in accordance with cGMPs.
Responsibilities
- Operate assigned machinery, including servicing machines with materials, monitoring equipment status, reintroducing materials, manually palletizing finished materials, and ensuring smooth product flow.
- Start-up machinery, including equipment set-up, recipe selection, data entry on manufacturing computerized systems (SCADA and HMI), making minor adjustments, and performing critical sensor challenges.
- Perform manual packaging tasks, including hand packaging and rework of in-process and finished materials.
- Operate light material handling equipment (motorized and manual pallet jacks, non-motorized lifts) to safely move, store, or deliver materials.
- Perform visual quality inspection and sampling of in-process materials; escalate concerns to Lead and Process Facilitator as needed.
- Perform minor troubleshooting, including clearing minor jams and identifying equipment defects; collaborate with technical resources to resolve issues.
- Perform inventory control and reconciliation activities using SAP and WES in a limited role.
- Perform cleaning, housekeeping, and line clearance activities, including assembling, disassembling, and sanitizing packaging equipment to maintain a cGMP environment.
- Complete batch record and GMP documentation entries; perform mathematical computations as needed.
- Follow job-related safety procedures and hazards, including PPEs, ergonomics, LOTO, human safety, material handling, chemical handling, and spill controls; report discrepancies to the process facilitator.
- Perform work in accordance with SOPs, cGMPs, and established safety and quality procedures.
- Support lean activities and process improvement, such as 5S, problem-solving, and manual tracking of performance data for OEE and process improvement analysis.
- Act as a certified OJT trainer on assigned equipment and process tasks; train and evaluate other team members for training qualifications.
- Review process documents (operational SOPs, forms, batch records) for accuracy; suggest process improvements while maintaining quality and cGMP compliance.
- Execute protocols as part of equipment qualification and process validation work.
- Support other work areas within the Manufacturing Team as needed.
- Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee.
- Acquire and maintain all required certifications and qualifications for the assigned work area.
- Learn new skills and develop capabilities to contribute to the success of the Process Execution Team.
- Work effectively in a team environment and adapt to a changing/demanding environment.
- Some overtime may be required with minimal advance notice to support business needs.
Requirements
- Experience in a pharmaceutical or cGMP regulated environment.
- Ability to effectively understand, read, write, communicate, and follow instructions in English.
- Good attention to detail; capable of keeping accurate records and performing mathematical calculations.
Qualifications
- High school graduate, vocational school graduate, or equivalent (preferred).
- Working knowledge of Microsoft applications and SAP (preferred).
- Prior production experience (preferred).
- Experience working in a LEAN manufacturing environment (preferred).
- Knowledge of cGMPs and FDA policies/procedures (preferred).
Pay
Our target base pay hiring range for this position is $21.50 - $32.00 per hour. Actual base pay is dependent upon geographical location, relevant experience, qualifications, skills, and knowledge.
Benefits
- Robust total rewards program, including an annual cash bonus program.
- 401(k) plan with a generous company match.
- Comprehensive healthcare benefits (medical, dental, and vision).
- Family-building benefits.
- Life and disability insurance.
- Flexible time off, paid holidays, and other paid leaves of absence.
- Tuition reimbursement.
- Support for caregiving needs.